Radiochemical Genotoxicity Risk and Absorbed Dose

Radiochemical Genotoxicity Risk and Absorbed Dose

Internal radiation exposure and genetic effects on birth outcomes. New and Important Evidence under Article 6.2 of the EURATOM Basic Safety Standards Directive 96/29 Submission to the BEIS meeting London Sept 12th 2017 Christopher Busby Scientific Secretary European Committee on Radiation Risk 1117 Latvian Academy of Sciences, Riga [email protected] www.greenaudit.org www.llrc.org

www.euradcom.eu www.ifrrr.org New and important Evidence In 1998 independent scientists, Alexey Yablokov, Inge SchmitzFeuerhake, Chris Busby, Alice Stewart, Rosalie Bertell and JeanFrancois Viel were invited to Brussels to advise the Green Group on the EURATOM Basic Safety Standards Directive 96/29. The conclusion was that the ICRP risk model was unsafe for internal exposures and that further evidence for this would emerge from the Chernobyl contaminated areas in the next 10 years. The group set up the European Committee on Radiation Risk (ECRR) to investigate the issue. They suggested that the Parliament introduce a safety clause so that if new scientific evidence emerged, the EURATOM BSS could be changed. As a result, Article 6.2 was included, requiring reJustification if new and important evidence emerged.

The EURATOM Basic Safety Standards Directive (BSS) is law in EU Member States Currently and from May 2000: Under Article 6.2 of the Council Directive 96/29/ Euratom of 13 May 1996: Existing classes or types of practice may be reviewed as to Justification whenever new and important evidence about their efficacy or consequences is acquired From 2018: Under Article 19.2 of the Council Directive 2013/59 of 5 th Dec 2013: Member States shall consider a review of existing classes or types of practices with regard to their justification whenever there is new and important evidence about their efficacy or potential consequences. In 1998 and today, the ICRP radiation risk model, developed in 1952 defines legal limits for exposures. It is based on the

epidemiology of the Japanese A-Bomb externally exposed groups in the Life Span Study (LSS) What is JUSTIFICATION? It is accepted that ionizing radiation causes harmful biological effects.

Cell death Organ damage Organism death (including infant deaths) Heritable damage (Congenital malformations) Lifespan shortening Cancer Heart and circulatory system disease Which evidence to examine in an epidemiological study? Studies of internal exposure and cancer are complicated by the long lag periods between exposure and expression, for solid tumours from 15-30 years. In this period, many other confounding causes might exist, exposure data lost, individuals die of other

causes or be lost to follow-up. Studies of immediate birth outcomes, congenital malformations, stillbirths, infant deaths, chromosome diseases, and objective biological genetic markers in children, are much easier to relate to the previous exposures. By 2017, more than 20 peer-reviewed studies had been published showing a clear increase in the rates of such heritable effects after Chernobyl. Taken together, these clearly represent New and Important Evidence within the meaning of the Black Letter Law of Article 6.2 of the EURATOM BSS. Genetic effects of Chernobyl was an issue where ECRR scientists had made some contributions Med Confl Surviv. 2009 Jan-Mar;25(1):20-40. doi: 10.1080/13623690802568954.

The evidence of radiation effects in embryos and fetuses exposed to Chernobyl fallout and the question of dose response. Busby C1, Lengfelder E, Pflugbeil S, Schmitz-Feuerhake I. Abstract Current legal frameworks for radiation exposure limits are based on the risk models of the International Commission on Radiological Protection (ICRP). In Publication 90 (2003), ICRP presents a safe (threshold) dose range of up to 100 mSv for radiogenic effects resulting from in utero exposure and bases this conclusion on the findings in Hiroshima and Nagasaki. However, a variety of observations of congenital malformations, fetal loss, stillbirths and infant deaths, as well as of Down's syndrome and other health defects in children after the Chernobyl accident exposures suggest that the A-bomb survivor data are incomplete. The Chernobyl findings are generally marginalized or even denied because of the low values of the estimated human exposures and the inconsistency of the results with the accepted risk models. One explanation for the observations is that physical dosimetric models have underestimated the effective

exposure. This possibility is supported by biological dosimetry in the contaminated regions. The assumptions about effects after in utero exposure by incorporated radionuclides need to be revised. I had been interested in the effects on genetic diseases from internal exposures from 1995 Busby Chris and Cato, Molly Scott (1998), Cancer in the offspring of radiation workers: exposure to internal radioisotopes may be responsible. British Medical Journal 316 1672 Busby, C. C. and Cato, M. S. (2000), Increases in leukemia in infants in Wales and Scotland following Chernobyl: evidence for errors in risk estimates Energy and Environment 11(2) 127-139 Busby C.C. and Cato M.S. (2001) Increases in leukemia in infants in Wales and Scotland following Chernobyl: Evidence for errors in statutory risk estimates and dose response assumptions. Kiev: International Journal of Radiation Medicine

Busby C and Fucic A (2006) Ionizing Radiation and childrens health: PINCHE conclusions Acta Paediatrica S 453 81-86 Busby C.C. (2009) Very Low Dose Fetal Exposure to Chernobyl Contamination Resulted in Increases in Infant Leukemia in Europe and Raises Questions about Current Radiation Risk Models. International Journal of Environmental Research and Public Health.; 6(12):31053114 Busby Chris, Lengfelder Edmund, Pflugbeil Sebastian, Schmitz Feuerhake, Inge (2009) The evidence of radiation effects in embryos and fetuses exposed by Chernobyl fallout and the question of dose response. Medicine, Conflict, Survival 25(1) 18-39 The reports of infant leukemia Increases after Chernobyl in several Countries of Europe caused us to discuss the issue with Mr Michael Meacher. This led to the founding

of the Committee Examining Radiation Risks from Internal Emitters, CERRIE. However the NRPB and industry members refused to concede the infant leukemia evidence and in the final report manipulated the dose levels. I will return to this issue When I consider the nuclear site child leukemia. Others had found evidence of the effects of Chernobyl on Birth Outcomes. Trend of infant mortality rates in Finland, Switzerland and Sweden, 1980 - 2006, and undisturbed trend line. Chernobyl effects based on official data (Koerblein 2009)

Yablokov, 2009 None of this evidence was discussed or cited by IRCP or UNSCEAR For 20 years the Scientific Secretary of the ICRP was Dr Jack Valentin until March 2009. He has been the editor of many of the ICRP reports Including the 2007 report. My discussion with him was recorded at an open meeting in Stockholm on 22nd April 2009 after he had retired early. He stated that the ICRP risk model could not be used to predict the health effects of radiation exposures in human populations because

the errors for certain internal exposures could be as high as 900-fold, and that the official risk agencies had been wrong in not looking at Chernobyl effects, but as Secretary he did what he was told. The video is on youtube. ICRP and heritable effects The ICRP states that there is no evidence of heritable effects of radiation in humans. This is because the studies of the Japanese ABomb groups apparently showed no evidence of increases in any birth defects or other genetic effects. The ICRP 2007 excess risk coefficient of 2% per

Sievert is based on external radiation experiments on mice. The Japanese A-Bomb studies cannot inform on the effects of internal radionuclides (or indeed anything). The Dose groups used for comparison were all exposed to internal radionuclides from the fallout and rainout, principally Uranium particles in the black rain. Internal exposures were ignored. Sawada has shown that individuals exposed to the black rain but as far as 6km from the hypocentre, and thus unexposed to external radiation, developed deterministic effects (epilation, diarrhoea) equivalent to 700mSv external exposure. The initially selected No Dose, Not in City NIC Group had been (dishonestly) abandoned in 1973 when employing it began to suggest that there was a

significant excess cancer risk in the lowest external dose group A 2009 study by Wanatabe et al used unexposed adjacent prefectures as controls and found significant excess cancer risk in the low external dose control group For birth outcomes, the study was begun 7 years after the event and suffered from all the control group problems above. Sex ratio genetic effects found were dishonestly interpreted. New and important evidence in 2016 Schmitz-Feuerhake I, Busby C, Pflugbeil S. Genetic Radiation Risks-A Neglected Topic in the Low Dose Debate. Environmental Health and Toxicology. 2016. 31Article ID e2016001. http://dx.doi.org/10.5620/eht.e2016001. Busby Christopher. (Invited) Letter to the Editor on The

Hiroshima Nagasaki survivor studies. Discrepancies between results and general perception. By Bernard R Jordan. Genetics. 2016; 204(4) 1627-1629 Schmitz-Feuerhake, Busby, Pflugbeil 2016 Objectives To investigate the accuracy and scientific validity of the current very low risk factor for hereditary diseases in humans following exposures to ionizing radiation adopted by the United Nations Scientific Committee on the Effects of Atomic Radiation and the International Commission on Radiological Protection. The value is based on experiments on mice due to reportedly absent effects in the Japanese atomic bomb (A-bomb) survivors. Methods To review the published evidence for heritable effects after ionising radiation exposures particularly, but not restricted to, populations exposed to contamination from the Chernobyl accident and from atmospheric nuclear test fallout. To make a compilation of findings about early deaths, congenital malformations, Downs syndrome, cancer and other genetic

effects observed in humans after the exposure of the parents. To also examine more closely the evidence from the Japanese Abomb epidemiology and discuss its scientific validity. Results Nearly all types of hereditary defects were found at doses as low as one to 10 mSv. We discuss the clash between the current risk model and these observations on the basis of biological mechanism and assumptions about linear relationships between dose and effect in neonatal and foetal epidemiology. The evidence supports a dose response relationship which is non-linear and is either biphasic or supralinear (hogs-back) and largely either saturates or falls above 10 mSv. Conclusions We conclude that the current risk model for heritable effects of radiation is unsafe. The dose response relationship is non-linear with the greatest effects at the lowest doses. Using Chernobyl data we derive an excess relative risk for all malformations of 1.0 per 10 mSv cumulative dose. The safety of the Japanese Abomb epidemiology is argued to be both scientifically and philosophically questionable owing to errors in the choice of control groups, omission of internal exposure effects and assumptions about linear dose response. Results show biphasic dose response. Due to death of

foetus at higher dose (From Busby 2017 in Press) Biphasic response infant leukemia (from Busby 2009) New and important evidence on Chernobyl heritable effects included

Lazjuk GI, Nikolaev DL, Novikova IV. Changes in registered congenital anomalies in the Republic of Belarus after the Chernobyl accident. Stem Cells 1997;15 Suppl 2:255-260 Feshchenko SP, Schrder HC, Mller WE, Lazjuk GI. Congenital malformations among newborns and developmental abnormalities among human embryos in Belarus after Chernobyl accident. Cell Mol Biol (Noisy-le-grand) 2002;48(4):423-426 Kulakov VI, Sokur TN, Volobuev AI, Tzibulskaya IS, Malisheva VA, Zikin BI, et al. Female reproductive function in areas affected by radiation after the

Chernobyl power station accident. Environ Health Perspect 1993;101 Suppl 2:117-123 Petrova A, Gnedko T, Maistrova I, Zafranskaya M, Dainiak N. Morbidity in a large cohort study of children born to mothers exposed to radiation from Chernobyl. Stem Cells 1997;15 Suppl 2:141-150 Wertelecki W. Malformations in a Chernobyl-impacted region. Pediatrics 2010;125(4):e836-e843 Wertelecki W, Yevtushok L, Zymak-Zakutnia N, Wang B, Sosyniuk Z, Lapchenko S, et al. Blastopathies and microcephaly in a Chernobyl-impacted region of Ukraine. Congenit Anom (Kyoto) 2014;54(3):125-149 Akar N, Ata Y, Aytekin AF. Neural tube defects and Chernobyl? Paediatr Perinat Epidemiol 1989;3(1):102-103 Caglayan S, Kayhan B, Menteolu S, Aksit S. Changing incidence of neural tube defects in Aegean Turkey. Paediatr Perinat Epidemiol 1989;3(1):6265 Gvenc H, Uslu MA, Gvenc M, Ozekici U, Kocabay K, Bekta S. Changing trend of neural tube defects in eastern Turkey. J Epidemiol Community Health 1993;47(1):40-41 Mocan H, Bozkaya H, Mocan MZ, Furtun EM. Changing incidence of anencephaly in the eastern Black Sea region of Turkey and Chernobyl. Paediatr Perinat Epidemiol 1990;4(3):264-268 Kruslin B, Juki S, Kos M, Simi G, Cviko A. Congenital anomalies of the central nervous system at autopsy in Croatia in the period before and after the Chernobyl accident. Acta Med Croatica 1998;52(2):103-107

Moumdjiev N, Nedkova V, Christova V, Kostova S. Influence of the Chernobyl reactor accident on the child health in the region of Pleven, Bulgaria. In: International Pediatric Association. Excerpts from the 20th International Congress of Pediatrics; 1992 Sep 5-10; Rio de Janeiro, Brazil. Vevey: Nestle Nutrition Services; 1992, p. 57 Zieglowski V, Hemprich A. Facial cleft birth rate in former East Germany before and after the reactor accident in Chernobyl. Mund Kiefer Gesichtschir 1999;3(4):195-199 (German). Scherb H, Weigelt E. Cleft lip and cleft palate birth rate in Bavaria before and after the Chernobyl nuclear power plant accident. Mund Kiefer Gesichtschir 2004;8(2):106-110 (German). Lotz B, Haerting J, Schulze E. Changes in fetal and childhood autopsies in the region of Jena after the Chernobyl accident; 1996 [cited 2016 Jan 28]. Available from: http://www.meb.uni-bonn. de/gmds/abstracts/0095e.html (German). And 36. Moumdjiev N, Nedkova V, Christova V, Kostova S. Influence of the Chernobyl reactor accident on the child health in the region of Pleven, Bulgaria. In: International Pediatric Association. Excerpts from the 20th International Congress of Pediatrics; 1992 Sep 5-10; Rio de Janeiro, Brazil. Vevey: Nestle

Nutrition Services; 1993, p. 57. 1992, p. 57. 37. Kruslin B, Juki S, Kos M, Simi G, Cviko A. Congenital anomalies of the central nervous system at autopsy in Croatia in the period before and after the Chernobyl accident. Acta Med Croatica 1998;52(2):103-107. 38. Zieglowski V, Hemprich A. Facial cleft birth rate in former East Germany before and after the reactor accident in Chernobyl. Mund Kiefer Gesichtschir 1999;3(4):195-199 (German). 39. Scherb H, Weigelt E. Cleft lip and cleft palate birth rate in Bavaria before and after the Chernobyl nuclear power plant accident. Mund Kiefer Gesichtschir 2004;8(2):106-110 (German). 40. Korblein A. Fehlbildungen in bayern nach tschernobyl. Strahlentelex 2004;416-417:4-6 (German). 41. Government of Berlin West, Section of Health and Social Affairs. Annual health report. Berlin: Government of Berlin West; 1987 (German). 42. Lotz B, Haerting J, Schulze E. Changes in fetal and childhood autopsies in the region of Jena after the Chernobyl accident; 1996 [cited 2016 Jan 28]. Available from: http://www.meb.uni-bonn. de/gmds/abstracts/ 0095e.html (German). 44. Busby C, Cato MS. Increases in leukemia in infants in Wales and Scotland following Chernobyl: evidence

for errors in statutory risk Estimates. Energy Environ 2000;11(2):127-139. Some specific examples: Belarus Lazjuk et al 1997 (Belarus National Genetic Monitoring Register) anencephaly, spina bifida, cleft palate, limb reduction defects, esophageal atresia, anorectal atresia, Downs syndrome, Multiple malformations: 80% increase 1987-94 vs. 1982-85 at 6.7mSv p<.05 gradient 49% at 0.44mSv. Whole of Belarus: all congenital malformations increased from 12.5 per 1000 in 1985 to 17.5 in 1994. Increase in frequency stabilised by State abortion intervention program. 7 other independent studies of areas of Belarus published by different groups with different levels of contamination, all below 10mSv confirmed the increases. (see ISF 2016 for list). Lazjuk GI, Nikolaev DL, Novikova IV. Changes in registered congenital anomalies in the

Republic of Belarus after the Chernobyl accident. Stem Cells 1997;15 Suppl 2:255260. Example--Ukraine: Wertelecki Wertelecki W. Malformations in a Chernobyl-impacted region. Pediatrics 2010;125(4):e836-e843 Wertelecki W, Yevtushok L, Zymak-Zakutnia N, Wang B, Sosyniuk Z, Lapchenko S, et al. Blastopathies and microcephaly in a Chernobyl-impacted region of Ukraine. Congenit Anom (Kyoto) 2014;54(3):125-149 Polissia (contaminated) vs. non Polissia, (lesser contamination). Doses <1mSv) Internal contamination measured. Among 145 437 live births in Rivne between 2000 and 2009 are included 2348 (1.61%) infants with anomalies noted before one year of age. This analysis concerns eight congenital malformations henceforth referred to as a group of cCM that includes conjoined twins, teratoma, NTD, microcephaly, mOPH, OM, gastroschisis, and exstrophy of the bladder. Overall frequencies of cCM, NTD, and spina bifida are statistically significantly higher in P

during both 5-year study periods, the frequencies of cranio-inien-rachis-schisis,MIC, and mOPH are statistically significantly higher only during the second 5-year study period. However, it is also evident that the frequencies of all of these cCM are higher in P during the first and second study periods. This fact, in our view, is biologically significant although in some instances such contrasts do not reach statistical significance, which is at least in part due to a limited number of observations Objective measurements: Alecsandra Fucic Fucic A, AghajanyanA, DrizhininV, Minina V, Neronova E (2016) Follow up studies in genome damage in children after Chernobyl Nuclear Power Plant Accident. Arch. Toxicol. DOI 10.1007/s00204-016-1766z From Abstract: Child population affected by internal and external radiation consisted of subjects exposed prenatally, postnatally (both evacuated and non-evacuated), born by irradiated fathers who worked as liquidators, and parents exposed environmentally. In

all groups of children during the last 30 years who were exposed to doses which were significantly higher than that recommended for general population of 1 mSv per year, increased genome damage was detected. Increased genome damage includes statistically higher frequency of dicentric and ring chromosomes, chromated and chromosome breaks, acentric fragments, translocations, and micronuclei. The presence of rogue cells confirmed internal contamination. Genome instability and radiosensitivity in children was detected both in evacuated and continuously exposed children. [email protected] Radiation genotoxicity. The 1946 Nobel prize for medicine was awarded to Herman J Muller for his discovery and subsequent work

on the mutations caused by X-rays which he discovered in 1926. By the 1950s Muller warned about the radioactive contamination being caused by the atmospheric nuclear tests causing genetic effects. His warnings turned out to be accurate. Effects of the 1960s atmospheric testing (from Busby 2017, International Conference on Applied Pharmacology and Toxicology Paris, June 22, 2017; in Press) Requests for re-Justification under Euratom BSS 96/29

Formal Requests for legally required re-Justification under BSS Article 6.2 have been made to the EURATOM National Contacts in UK, Ireland, Sweden, Denmark, France and Germany. The issue was submitted in presentations to the Swedish Land and Environmental Court, the Nacka Tingsrtt, a few days ago on 8th and 11th September. Failure to implement the Black Letter Law will result in applications to the European Commission and European Court for intervention of an Infringement. Peer Review Article Busby Christopher (2017) Child health and ionizing radiation: Science, Politics and European Law. Pediatric Dimensions. 2(3) 1-4

doi:10.15761/PD.1000150 The history of Science has been full of major changes in scientific models. But none of these, from Galileo, Newton, Einstein, etc. can have had quite the public health impact as the revelation that internal radionuclide exposures are so genotoxic and that the model employed to quantify these exposures is totally unsafe. Politicians and radiation risk agencies and experts are now caught between human health and economic (nuclear energy, fracking) and military (nuclear weapons, depleted uranium) projects which depend upon permitting radioactive contamination. COMARE, nuclear sites and child leukemia: an explanation. Biphasic response and foetal death; dose related variable lag period due to clonal expansion of damaged cells gives expression at different ages. Expression in utero results in foetal death. Pre-leukemic children have compromised immunity and high

risk of death from other causes (Lichtenstein). COMARE: Child leukemia at sites where nuclear stations were planned Such sites are all near the sea or on estuaries and subject to seato-land transfer of radionuclide contamination. A sea-coast and estuary effect for child leukemia was found by Alexander and Cartwright in 1990 Sea coast effects on leukemia and cancer were found by Busby 1998-2001 for Irish Sea populations, presented to CERRIE and published in 2007 Sea coast effect on child leukemia was discussed for Galloway populations: Busby Chris (2008) Is there a sea coast effect on childhood leukaemia in Dumfries and Galloway, Scotland, 1975-2002 ?

Occupational and Environmental Medicine 65, 4, 286-287 Non-Chernobyl reports of excess heritable damage at low doses Hanford USA workers children Sever et al 1988

Sellafield workers stillbirths Parker et al 1996 Liquidators Obninsk CA Tsyb 2004 Liquidators Bryansk CA Matveenko 2005 Liquidators Russia CA Lyaginskaya et al 2009 British Nuclear test Veterans Rabbitt Roff 1999 British Nuclear Test Veterans Busby et al 2013 3 Studies of CA following Uranium weapons in Fallujah Iraq Alaani et al,2010,2012. Busby et al 2011 Fallujah Iraq: Uranium weapons ALAANI, S., AL-FALLOUJI, M., BUSBY, C*., HAMDAN, M.. Pilot study of congenital anomaly rates at birth in Fallujah, Iraq, 2010. Journal of the Islamic Medical Association of North America, North America, 44, Aug. 2012. Available at: <

http://jima.imana.org/article/view/10463>. Alaani Samira Tafash Muhammed, Busby Christopher*, Hamdan, Malak and Blaurock-Busch Eleonore (2011) Uranium and other contaminants in hair from the parents of children with congenital anomalies in Fallujah, Iraq Conflict Health 5, 1-15 Busby, Chris*; Hamdan, Malak; Ariabi, Entesar. (2010) Cancer, Infant Mortality and Birth Sex-Ratio in Fallujah, Iraq 20052009. Int. J. Environ. Res. Public Health 7, no. 7: 2828-2837. British Nuclear Test Veterans Busby et al 2013 Busby C and de Messieres M (2014) Miscarriages and congenital conditions in offspring of the British Nuclear Atmospheric test Program. Epidemiology 2014, 4:4 http://dx.doi.org/10.4172/2161-1165.1000172

Questionnaire epidemiological study of members of the British Nuclear Test Veterans Association. Comparison with National EUROCAT data and controls. Congenital Malformation in children OR = 9.8; in grandchildren OR = 8.3. Miscarriages OR = 2.7. Similar effects found by Rabbitt Roff 1999. Note the genomic component. Fracking and Radium Busby Christopher and Mangano Joseph J. Theres a world going on undergroundinfant mortality and fracking in Pennsylvania. Journal of Environmental Protection. 8(4) 2017 doi: 10.4236/jep.2017.84028

Using official 0-28d infant mortality rates in the highly fracked counties of Pennsylvania relative to the non-fracked counties before and after fracking began showed a statistically significant 28% excess rate in the fracked counties after fracking began. The effects was related to density of drinking water wells. For the counties with high density the excess was a significant 66%. The authors discussed evidence for exposure to Radium in groundwater. Theoretical Explanations The effects are due to the dose to the DNA, or rather the ionization density at the DNA. This is very much greater than the mean tissue dose for those internal radionuclides with chemical affinity for DNA,

e.g, Strontium-90, Uranium, Radium, Barium-140. This is reviewed in: Busby Christopher (2013). Aspects of DNA Damage from Internal Radionuclides, New Research Directions in DNA Repair, Prof. Clark Chen (Ed.), ISBN: 978-953-51-1114-6, InTech, DOI: 10.5772/53942. Available from: http://www.intechopen.com/books/new-research-directions-in-dna-r epair/aspects-of-dna-damage-from-internal-radionuclides Busby Christopher (2017) Radiochemical Genotoxicity and Absorbed Dose. Keynote presentation. 9th International Conference on Applied Pharmacology and Toxicology, Paris, June 22, 2017

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